ALX Oncology's Evorpacept Shows Strong Response in Gastric Cancer…

Event summary

ALX Oncology published Phase 2 ASPEN-06 trial data in Nature Medicine, showing evorpacept plus trastuzumab, ramucirumab, and paclitaxel achieved a 40.3% objective response rate (ORR) vs. 26.6% for the control in HER2-positive gastric cancer.
Subgroup analysis revealed a 63.6% ORR in patients with high CD47 expression and retained HER2-positive disease, vs. 23.1% for the control.
The company plans to focus on the ongoing Phase 2 ASPEN-09-Breast trial, with topline data expected mid-2027.

The big picture

ALX Oncology's positive Phase 2 data for evorpacept in HER2-positive gastric cancer reinforces the growing importance of biomarker-driven immuno-oncology therapies. The results highlight the potential of CD47 as a predictive biomarker, a trend gaining traction in precision medicine. The company's focus on the ongoing breast cancer trial suggests a strategic pivot towards indications with higher unmet need and regulatory clarity.

What we're watching

Biomarker Validation: Whether CD47 expression can be consistently validated as a predictive biomarker for evorpacept's efficacy across different cancer types.
Clinical Trial Progress: The pace at which the Phase 2 ASPEN-09-Breast trial progresses and whether it replicates the strong responses seen in the gastric cancer trial.
Partnership Strategy: How ALX Oncology will leverage these results to pursue development partnerships for evorpacept in gastric cancer, given its decision to forgo a Phase 3 trial.